Urethral urine retention device

ABSTRACT

An apparatus for sealing at least a portion of the urinary tract to prevent the unwanted discharge of urine includes a body member with a tubular member, encircled along its length by an overcoat layer, that encases a fluid, forming a cavity. The body member, with its tubular member and overcoat layer are elastically deformable from an initial “rest” or “relaxed” state, when outside of the body, where at least a portion of the overcoat layer is of a diameter equal to or greater than that of an undilated urethra. A stylet may be placed into the tubular member to serve as a guide, for elongation of the body member and to provide rigidly to the body member upon insertion into the urinary tract. There is also disclosed a method for making the apparatus of the present invention.

This application is a Continuation of application Ser. No. 08/637,858,filed Apr. 25,1996 now U.S. Pat. No. 5,906,575, which application(s) areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to devices for treating incontinence andother similar problems in humans, and in particular to devices, andmethods for their manufacture, that serve to form a seal with at least aportion of the urinary tract, to prevent the unwanted discharge of urinefrom the urinary tract.

BACKGROUND OF THE INVENTION

Urinary incontinence is a problem faced by both women and men. The mostcommon form of incontinence is known as stress incontinence, andincidences of this form of incontinence are significantly higher inwomen than in men. Many different forms of treatment are currently inuse.

Although most incontinent people are not treated with indwellingcatheters, some (for example, certain comatose patients) may not havealternatives other than using indwelling urinary catheters. Urinarycatheters that are not indwelling or self-retaining, but can beintermittently inserted into the urinary tract for periodic (orintermittent) drainage, have also been used for fully draining thebladder. Such catheters usually are simple smooth tubes with roundedtips for ease of insertion and therefore are not self-retaining. A draineyelet is present near the tip of the catheter to allow urine to enterthe catheter. Such simple devices may be self-administered by thepatient. Many incontinence problems can be helped by the use of suchintermittently administered devices. However, for many incontinentfemale patients, unlike males who can wear external urinary catheters,during the period between drainage using intermittently administeredcatheters, diaper products must be used. Such diaper products are bulky,inconvenient, and may result in embarrassing situations for the patientif not attended to properly.

Another type of intermittently administered devices include urethralplugs. These plugs, including Foley catheters that are clamped off, aredesigned to be placed in the urethra and/or the bladder neck, and oncein position, in the urethra or bladder neck, are expanded by inflationwith gas (air), liquid, or the like. This inflation is typicallyperformed by connecting a syringe, filled with air or liquid, with avalved tube built within the plug body. Before removal, the expandedportion of the plug, must be deflated. Both the inflation and deflationprocesses require the user to be capable of properly expanding anddeflating the device, in order to properly insert it and remove it, andso as not to damage the urethra. These devices require manual deflationprior to removal from the urinary tract, such that an incapacitated(e.g., unconscious) user would risk overfilling of the bladder, causingsevere kidney damage and even death.

These conventional plugs are relatively costly to manufacture, anddisposable plugs, used once between voidance, are preferred in order tomaintain sterility to avoid infection. Accordingly, manufacturing costsare a significant factor in commercial viability of disposable plugdevices.

Traditionally, catheter manufacturing methods, such as those for makingFoley catheters include processes that involve slipping a band of curedrubber over a double lumen latex rubber tubing and affixing the band onthe double lumen tubing by dipping the band and the tubing in asuspension of latex to form an outer layer. The cost of manufacturingtraditional Foley catheters has been influenced by the need to use asignificant amount of hand labor to make the devices.

It will be appreciated that using such traditional methods to makecatheters and other polymeric structures that have a variety of outershapes and sizes with cavities (especially fluid-filled cavities)between the tubing and the outer layer adds significantly to the cost ofproduction. Moreover, in many cases where a polymeric structure such asa catheter is to have a cavity filled with fluid, traditionalmanufacturing methods can not be used.

In addition to catheters, numerous devices such as gastronomy devicesfor transporting fluids into and out of various segments of thegastrointestinal system, for example, the stomach, also have a structureof an overcoat layer on an inner tubular structure defining a cavitytherebetween. Many devices also require a self retention capability suchas in the case of external feeding tubes.

Providing an automated method of manufacturing these polymericstructures and others would reduce the cost of many productsincorporating such polymeric structures so that they would be morecompetitive in the market place and could be used for disposableproducts where low cost is essential.

The present invention includes polymeric structures, especiallypolymeric structures with encapsulated fluid filled cavities. Inaddition, the present invention provides methods for manufacturing thedevice of the present invention, that offer substantial advantages overtraditional manufacturing methods.

SUMMARY OF THE INVENTION

The present invention improves on the prior art by providing a singleuse (used once between voidance) disposable urethral device, thatrequires minimal user skill for insertion and removal and ismanufactured at a low cost. The device of the invention is preferablydesigned to work within the mammalian urinary tract, whose mainstructures include, but are not limited to, the meatus urinarius,urethra, bladder neck and bladder. More specifically, the device ispreferably designed for use in the urinary tract of a human female, toblock the flow of urine when deployed therein. The device is designed toexert a pressure in response to that of the structures of the urinarytract, such that the device can be removed from the urinary tract, andultimately the body, by the user, manually initiating deformation of thedevice, or simply by voiding (urinating).

Voidance will normally dislodge the device of the invention in and fromthe urinary tract and out of the body. Accordingly, the device of theinvention provides the user with an added degree of safety. For example,if the user were incapacitated, unconscious, or in other similarimpaired conditions, voidance would occur naturally, such that thedevice would be forced out of the body. As a result of the invention,unlike the conventional plugs, urine would not remain in the bladder andback up in the kidneys, so as to severely damage the kidneys bladder andother structures of the urinary tract, or result in death to the user,until medical or other personnel could attend to removing theseconventional plugs.

In human females, the urethra is about 4 cm in length, Gray's Anatomy,Thirty-Eighth Edition, Pearson Professional Limited (1995), and itsundilated diameter is about 6 mm (0.25 in), Tortora, Principles of HumanAnatomy, Sixth Edition, Biological Sciences Textbooks, Inc. (1992). Itis commonly flaccid when in its normal undilated state. While in thisundilated state, the urethra commonly has a ribbon-like shape. Upontypical dilations, such as the passage of urine during voidance, theurethra takes a rounded ovular or flattened tube shape, and expands suchthat the cross-sectional diameter (hereafter diameter) increases fromthat of the urethra in the undilated state. It is this undilateddiameter of the urethra that will be referenced throughout thisapplication as the “diameter”, for purposes of uniformity, as it is wellknown that the urethra can be dilated into many shapes (cross sectional)of varying diameter.

The device is such that it is typically of a shape with a portionthereof having a diameter greater than that of an undilated urethra, butcan be deformed by urethral wall pressure such that the diameter changesat various points along the urinary tract, for insertion, deployment andremoval therefrom. Use of this device allows the user complete freedomof movement without fear of urine leaking from the urinary tract as aresult of body reflexes such as sneezing, coughing, laughing, straining,freeing the user from diapers tubes or the like, that are oftenembarrassing to the user.

The present invention also relates to methods of making polymericstructures (i.e., urethral devices) where a cavity is formed between aninner polymeric layer and an outer polymeric layer. These polymericstructures are formed as shaped structures, and in particular, theshaping is of the cavity. These shaped cavities may be fully orpartially filled with fluid (liquid or gas) or not filled at all. Theymay also be filled with a solid piece, or combinations of solids,liquids and/or gases.

The shaping may be achieved by coating an inner piece (e.g., a polymerictube or shaft) with single or multiple coatings of bond-preventingagent(s), in various steps. The coating of bond-preventing agentremaining on the inner piece, before the coating of a liquid polymericovercoat layer, is herein referred to as the “residual coating.” Theshape of the overcoat layer results from the varying thickness of theresidual coating of the bond-preventing agent.

The residual coating, that gives shape to the overcoat layer, isachieved by coating portions of an outer surface of the inner piece witha bond-preventing agent in a plurality of dipping steps by immersing theinner piece into the bond-preventing agent to a desired depth for adesired length of time and subsequently removing the inner piece fromthe bond-preventing agent. The desired depth and the desired length oftime for each of the plurality of dipping steps is selected so that aresidual coating of bond-preventing agent of a desired thickness andshape remains on portions of the inner piece following the plurality ofdipping steps.

The residual coating has a specific shape as a result of the variationbetween the depth of any two of the multiple of dipping steps, thenumber of dipping steps, the length of time between any two of themultiple dipping steps, and the varying speeds of withdrawal from thetanks of bond-preventing agent and stripping agents. By appropriatecoating (with bond-preventing agent) and stripping (with strippingagents), the bond-preventing agent can be sculpted to result in desiredshapes, as is achievable using conventional technology such as lathes.

The sculpted residual coating can have varying thickness, curves, andangles, and therefore, a specific desired shape. By subsequently coatingthe residual coating of bond-preventing agent, that coats the innerpiece with a polymeric bonding composition, a shaped overcoat layer isformed wherein the shape of the overcoat layer results from the varyingshape of the residual coating.

As used herein, two structures of similar shapes, but having unequalratios of dimensions in the two structures are considered to havedifferent shapes. For example, annular cylinders with the same insidediameter and length but different outside diameters are not consideredto have the same shape.

In making the polymeric structures of the present invention, with themethod of the present invention, the outside dimensions (e.g., diameter)can be made with more consistency than in similar products made bytraditional manufacturing methods. The methods of the present inventionmake possible the highly automated process of fabricating polymericstructures with shaped gel-filled, liquid-filled or air-filled cavities,especially those with a soft, outer, elastomeric layer that can conformto the contour of a surface in contact therewith.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described with reference to theaccompanying drawings, wherein like reference numerals identifycorresponding or like components.

In the drawings:

FIG. 1 is a cross sectional view of the present invention;

FIG. 2 is a front view of the present invention;

FIG. 3 is a rear view of the present invention;

FIG. 4 is a cross sectional view of the present invention with a styletremoved therefrom;

FIGS. 5-8 are cross sectional views of the present invention in use uponinsertion into the urinary tract of a human female;

FIG. 9 is a cross sectional view of the present invention upondeployment into the urinary tract of a human female; and

FIGS. 10 and 11 are cross sectional views of the apparatus of thepresent invention upon removal from the urinary tract of human female.

FIG. 12 is a side view of a mandrel for making an embodiment of thepresent invention;

FIG. 13 is a schematic representation of a production line includingprocessing stations for manufacturing the present invention;

FIG. 14 is a schematic illustration of an apparatus, including a diptank and a transport mechanism used in the production of the presentinvention;

FIG. 15 is a schematic representation of the automated controls for theapparatus shown in FIG. 14, used to automate the production of thepresent invention; and

FIGS. 16-22 are cross sectional views of the manufacturing steps used inmaking the apparatus of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Turning now to FIGS. 1-4, there is shown the apparatus 20 of theinvention. The apparatus 20 comprises a deformable body member 21. Thebody member 21 is formed of a tubular member 22, encircled along itslength by an overcoat layer 24. The space between the tubular member 22and the overcoat layer 24 defines a cavity 26, in which fluid 27 isencased. The apparatus 20 preferably also includes a removable stylet28, received within the inner body of the tubular member 22, fordeploying the apparatus 20 in the urinary tract.

The tubular member 22 includes an elongated hollow bodied shaft 30, witha tip region 32, terminating in a closed tip 33 that closes the tubularmember 22 at its distal end 34. The shaft 30 terminates in a stoppermember 36 at the proximal end 38 of tubular member 22. The proximal end38 is open to allow for ingress and egress of the removable stylet 28,accommodated by the hollow inner body of the shaft 30. The stylet 28provides the apparatus 20 with stiffness for proper insertion into theurinary tract through the urethra 72 (FIGS. 5-11), with a portion of theapparatus 20 (i.e., the tip 33 and the distal portion of the overcoatlayer 24) ultimately extending into the bladder neck 76 or bladder 78(FIGS. 5-11).

The shaft 30 is preferably tubular in shape. The inner diameter of theshaft 30, is preferably formed of a circular bore that provides theshaft 30 with a hollow inner body. This hollow inner body issubstantially uniform along its entire length, and decreases at the tipregion 32 (as it closes in the tip 33). The outer diameter of the shaft30 is substantially uniform, except in the tip region 32, that ispreferably greater than the remainder of the shaft 30 as this tip region32 is thickened with additional material layers (placed onto the shaft30 in accordance with the manufacturing process disclosed below),preferably of silicone rubber. This outer diameter of the shaft 30, evenat its largest in the tip region 32, is preferably less than thediameter of the undilated urethra. This added material at the tip region32 provides the tip region 32 with additional rigidity for ease ofinsertion into the urethra 72 (FIGS. 5-8), and prevents the possibilityof the stylet 28 from breaking through the tip 33.

The stopper member 36, attached to the shaft 30 at the proximal end 34of the tubular member 22, forms a common opening 42 with the shaft 30.The stopper member 36 extends outward from the shaft 30. This stoppermember 36 is preferably boat-like in shape, with its length and widthbeing greater than the diameter of the shaft 30. This boat-like shape,coupled with these dimensions allows the stopper member 36 to be grippedand retained easily by the user 80 (FIGS. 10 and 11) as well asproviding a barrier against over-insertion into the urethra.Additionally, the boat-like shape allows the stopper member 36 toreceive a correspondingly configured (preferably round) bar 60 on thestylet 28, that preferably abuts the inner surface 43 of the stoppermember 36 (to serve to limit travel of the stylet 28 in the tubularmember 22), when the body member 21, with its tubular member 22 andovercoat layer 24, is elongated and deformed during insertion of theapparatus 20 into the urinary tract.

The shaft 30, including the tip region 32 (and closed tip 33), andstopper member 36, that form the tubular member 22, are preferably anintegral member, and formed a single piece during the manufacturingprocess (detailed below). However, multiple piece construction withfastening by conventional materials fastening techniques is alsopermissible.

It is preferred that the tubular member 22 is preferably made of anelastomeric material, that is also preferably medically acceptable, suchas silicone rubber (elastomer), in order that it be elasticallydeformable. Some suitable silicone rubbers commercially availableinclude General Electric 6030 (GE 6030) and Dow Corning Q7-4850.Silicone is also preferred, as many people, perhaps 10 to 20 percent ofthe world population, are allergic to latex or latex based materials,some of these allergic reactions being severe as to result inanaphylactic shock, that is fatal in extreme cases.

Additionally, silicone rubber can accommodate common surgical lubricantstypically, used with the placement of urinary devices, withoutdeteriorating or chemically breaking down. A silicone rubber tubularmember 22 can be made by forming the tubular member 22 with uncuredsilicone rubber and then curing it, in accordance with the methoddetailed below. The uncured silicone rubber for making the tubularmember 22 is preferably one that will result in a silicone rubber of30-70 durometer, preferably 30-40 durometer, and can be an uncuredsilicone rubber dispersion of uncured silicone rubber in heptane,toluene, naphthalene, hexamethyl disiloxane or other suitable solvent.General Electric 6030 silicone rubber and Dow Corning Q7-4850 aresuitable silicone rubbers for forming the dispersion.

It is to be appreciated that other suitable, medically acceptablepolymeric materials may be used. These other suitable materials formanufacturing the tubular member 22 include block copolymers (such asstyrene-butadiene-styrene), urethanes and latex rubbers. Additionalmodifications to the tubular member 22 are disclosed in themanufacturing process below.

The overcoat layer 24 encircles the shaft 30 of the tubular member 22along a substantial portion of the length of the shaft 30. This overcoatlayer 24 encases the fluid 27 in the cavity 26, such that it remains inthe cavity 26 for the life of the apparatus 20. The overcoat layer 24comprises of a bulbous portion 44, distally positioned on the shaft 30and a sleeve portion 46, proximally positioned on the shaft 30. Theovercoat layer 24 is such that its cross-sectional diameter (hereafterdiameter) along at least a portion of either of its bulbous 44 and/orsleeve 46 portions, is at least equal to, and preferably greater thanthe diameter of the undilated urethra. The bulbous portion 44 iscontinuous with the sleeve portion 46. The sleeve portion 46 ispreferably generally cylindrical and tapers outwardly (from roundedcorners 48) to join the bulbous portion 44. The diameter of the bulbousportion 44 at its widest point is preferably greater than the diameterof the sleeve portion 46. However, the diameters of the bulbous portion44 and the sleeve portions 46 could also be equal. The cavity 26, formedin the space between the overcoat layer 24 and the shaft 30, ispreferably continuous, valveless and filled with a fluid 27, thatremains encased therein.

The fluid 27 is preferably mineral oil but could also be a soft moldablesemisolid such as petrolatum, petroleum jelly or a combination thereof.The fluid 27 could also be a gas, such as air or the like. The overcoatlayer 24 is preferably an elastomeric material, such as silicone rubber,in order that it be elastically deformable such that the encased fluid27 can flow from end to end therein when subject to pressure of theurethral walls that deform the overcoat layer 24 upon deployment in andremoval from the urinary tract, while keeping the encased fluid fromleaking from the cavity 26. The fluid 27 also serves to absorb shockfrom twisting or other movement of the shaft 30 when the apparatus 20 isdeployed in the urinary tract. The fluid 27 also allows the overcoatlayer 24 to conform to the general shape (including the diameter) of theurethra (and preferably the bladder neck upon deployment), when theurethra is either undilated (flaccid) or dilated, and any irregularitiesin the urethra or other portions of the urinary tract.

The overcoat layer 24 is of an elastomeric material (discussed below)that has a natural shape retaining memory. Coupled with the underlyingfluid filled cavity 27, the overcoat layer 24 gently resists pressure ofthe urinary tract, in particular that from the urethral walls 74 (FIGS.5-11) and the bladder neck 76 (FIGS. 5-11), by exerting a back pressureon the urethral walls 74 and the bladder neck 76. This gentle pressureengagement generally allows for the natural closure of the urethra 72 byforcing fluid 27 in the cavity 26 to the cavity portion within thebulbous portion 44 of the body member 21. At weaker points along theurinary tract, where full closure is not normally achieved (inincontinent mammals, such as humans), the body member 21 assists inattaining such closure, by providing a soft comfortable surface aroundwhich the structures of the urinary tract, for example, the urethra andbladder neck can close. At minimum, the pressure between the urethralwalls 74 and the overcoat layer 24 is sufficient to seal the urethra 72,blocking the flow of urine therein. However, this resistance pressurefrom the overcoat layer 24 is less than that of the force of the urinebeing expelled from the bladder 78 during voidance, such that the forceof voidance is sufficient to deform and dislodge the body member 21 fromthe urinary tract, and ultimately to a point outside of the body.

The overcoat layer 24 is preferably made of silicone rubber (elastomer),to be elastically deformable. Also, as stated above, silicone rubber isa medically acceptable material and is not known to give rise to thepotential allergic effects of latex or latex-based materials.Additionally, silicone is preferred for it can accommodate commonsurgical lubricants, used with the placement of urinary devices, withoutdeteriorating or chemically breaking down. However, other suitablematerials such as block copolymers (e.g., styrene-butadiene-styrene),latex or other synthetic rubbers may also be used. The overcoat layer 24is placed onto the tubular member 22 along the shaft 30 by themanufacturing method described below, or by other appropriate methods.

The stylet 28 is a stiff, slightly flexible rod, that is removablyinserted into the tubular member 22 through the opening 42 at theproximal end 38 of the tubular member 22. The stylet 28 has a body 50 ofa diameter slightly less than the inside diameter of the shaft 30 of thetubular member 22 for easy insertion and withdrawal. The body 50 has around or blunt tip 52 at its distal end 54 and an end member 56, at theproximal end 58 of the stylet 28. The end member 56 is knob-like andshaped for a user's hand 80 (FIGS. 10 and 11) to comfortably pressthereon to urge the stylet 28 into the shaft 30 of the tubular member22, and bear against the tip 33 of the tubular member 22. A bar 60, isintermediate the tip 52 and end member 58, disposed preferably towardthe proximal end 58 of the body 50 in an orientation that is generallyperpendicular to the axis of the body 50. The stylet 28 is preferablymade of polycarbonate or other similar plastic to give the apparatus 20the necessary rigidity to facilitate the insertion of the apparatus 20into the urinary tract.

The length of the stylet 28 is greater than the length of the tubularmember 22, such that when the stylet body 50 is inserted all the wayinside the shaft 30, with the distal end 56 of the stylet 28 bearingagainst the tip 33 of the tubular member 22, the end member 56 of thestylet 28 is outside of the stopper member 36. With the body member 21in this “rest” or “relaxed” state, the bar 60 is approximately 1.5 cmaway from the opening 42 at the interface of the shaft 30 and stoppermember 36 (FIG. 1). Upon elongation (and deformation) of the body member21 (tubular member 22 and overcoat layer 24), the bar 60 may be moved asfar as into abutment with the stopper member 36, such that the stylet 28is firmly within the hollow inner body of the tubular member 22 as theapparatus 20 is inserted into the urinary tract (shown in FIGS. 5-11 anddescribed below).

The preferred embodiment of the apparatus 20 and body member 21 is smallso as to be adapted for the human urinary tract. In one example, thebody member 21 is preferably approximately 5 cm to 8 cm (1.97 in to 3.15in) in length, and more preferably, approximately 4.42 cm (1.74 in),approximately 5.40 cm (2.13 in), or approximately 6.30 cm (2.48 in), toaccommodate “short”, “medium” and “long” urinary tracts, respectively.Along the body member 21, the tip region 32 is preferably approximately0.25 cm to 0.76 cm (0.1 in to 0.3 in) in length, and more preferablyapproximately 0.50 cm (0.2 in), the bulbous portion is preferablyapproximately 0.76 cm to 2.03 cm (0.3 in to 0.8 in) in length, and morepreferably approximately 1.52 cm (0.6 in) and the sleeve portion 46 ispreferably approximately 1.24 cm to 3.63 cm (0.49 in to 1.43 in) inlength, and more preferably approximately 1.50 cm (0.59 in), 2.49 cm(0.98 in), or 3.38 cm (1.33 in), while the distance between the sleeveportion 46 and the stopper member 36 on the tubular member 22 ispreferably approximately 0.76 cm to 1.27 cm (0.30 in to 0.50 in), andmore preferbaly approximately 1.02 cm (0.40 in). The outer diameter ofthe tubular member 22, at the shaft 30 and tip region 32 is preferablyapproximately 0.25 cm to 0.40 cm (0.10 in to 0.16 in), and morepreferably approximately 0.33 cm (0.13 in), the outer diameter of thebulbous portion 44 at its widest point is preferably approximately 0.89cm to 1.65 cm (0.35 in to 0.65 in), and more preferably approximately1.02 cm (0.40 in), 1.27 cm (0.50 in) or 1.52 cm (0.60 in), and the outerdiameter of the sleeve portion at its midpoint is preferablyapproximately 4.5 mm to 7.0 mm (0.18 in to 0.28 in), and more preferablyapproximately 5.3 mm (0.21 in), 6.0 mm (0.24 in) or 6.7 mm (0.26 in).The stopper member 36 tapers outward from the shaft 30 of the tubularmember 22 to a diameter at its widest point of preferably approximately2.3 cm (0.9 in).

Alternate embodiments of the apparatus 20, and in particular the bodymember 21, that operate nearly identical to the embodiment disclosedabove, could be adapted for the male urinary tract, and in particular,for the urinary tract of a human male, the human male urethra beingapproximately 20.3 cm to 22.9 cm (8 in to 9 in) in length. Thesealternate embodiments, adapted for the male urinary tract, would besimilar to the above described, embodiments, and may be sized smaller inlength than the above described embodiments, for the tubular member,i.e., the shaft thereof, and the overcoat layer encircling the shaft,need only be of a length sufficient to extend into the spongy portion,approximately the first 15.2 cm (6 inches) from the meatus having adiameter of approximately 6.3 mm (0.25 in), of the human male urethra.

Other alternate embodiments of the apparatus 20 of the present inventioninclude slight modifications to the body member 21, in the embodimentsadapted for the urinary tracts of both the mammalian female andmammalian male to make it a retention catheter. These retention catheterembodiments include an eyelet (opening), extending through the tubularmember 22, preferably at the tip region 32, to allow bodily fluid, suchas urine, to enter the hollow inner body of the shaft 30 (that serves asa drainage tube) of the tubular member 22, where it would enter anadditional drainage tube, this drainage tube adapted to be received bythe terminal opening 42. Alternately, the stopper member 36 need not bepresent at all and the shaft 30 of the tubular member 22 could beextended as long as desired, to function as the drainage tube.

Turning now to FIGS. 5-11, there is shown the apparatus 20 of theinvention upon deployment, use and removal from the urinary tract of ahuman female. The apparatus is preferably lubricated with water basedlubricant, or other commonly used surgical lubricant.

Initially, as shown in FIG. 5, the apparatus 20, with the body member 21in its rest state (unelongated and undeformed) is placed into contactwith the meatus 70, such that the distal tip region 32 has entered theurethra 72. In this initial state, the overcoat layer 24, of the bodymember 21 with its bulbous 44 and sleeve 46 portions, is of a diameterequal to or greater then the diameter of the undilated urethra along atleast a portion thereof. With the body member 21 in an unelongatedstate, the stylet 28, rests in the shaft 30 and tip region 32 of thetubular member 22, such that bar member 60 is approximately 1.5 cm fromthe stopper member 36.

Turning to FIG. 6, there is shown the initial insertion of the apparatus20 into the urinary tract of a human female via the urethra 72. Thestylet 28 has been moved such that the bar member 60 abuts the innersurface 43 of the stopper member 36, elongating the shaft 30 of thetubular member 22. The now elongated overcoat layer 24, and the shaft30, and tip region 32 of the tubular member 22, all narrow in diameter,and coupled with the rigidity of the stylet 28, insertion of the bodymember 21 in the urethra 72 may continue easily. Upon insertion, theurethral walls 74 provide their natural resistance, this resistancepressing on the overcoat layer 24, and in particular the fluid-filledbulbous portion 44, resulting in fluid 27 in the cavity 26 being pushedback into the sleeve portion 46, further reducing the bulbous portion 44diameter for ease of insertion.

FIG. 7 details insertion proceeding until at least the tip region 32 andpart of the bulbous portion 44 enters the bladder neck 76. Insertion iscomplete, as shown in FIG. 8, when the stopper member 36 abuts themeatus 70, the diameter of the stopper member 36 prohibits furtherinsertion of the body member 21. Additionally, the distal tip region 32and part of the bulbous portion 44 extends at least into the bladderneck 76, and preferably with its distal tip 33 in the bladder 78.

With insertion complete, the stylet 28 has been removed, as shown inFIG. 9. Pressure from the urethra walls 74, forces fluid 27 back intothe bulbous portion 44, this urethral wall pressure may compress theovercoat layer 24 at the sleeve portion 46, such that the fluid volumein the bulbous portion 44, that has entered the bladder neck 76, oralternately, the bladder neck 76 and bladder 78, may be greater than itwas prior to insertion of the apparatus 20, and the diameter of thebulbous portion 44 may be greater than it was initially, prior toinsertion.

With the stylet 28 removed, the body member 21 relaxes to itsunelongated state, and is now properly seated in the female urinarytract. The entire overcoat layer 24 is now in the urinary tract, withpart of the bulbous portion 44, and the tip region 32 of the shaft 30extending into the bladder neck 76 or bladder 78, while part of thebulbous portion 44 seats at the bladder neck 76, effectively blockingurine flow and effectively retaining the body member 21 in the urinarytract. The natural memory of the overcoat layer 24 coupled withunderlying fluid filled cavity 26 serves to maintain a gentle pressure,exerted by the bulbous 44 and sleeve 46 portions within the urethra 72,on the urethral walls 74, in response to the pressure exerted by theurethral walls. The resistance of this overcoat layer 24 is such that itconforms to the ribbon-like shape of the urethra 72, effectively sealingthe urethra 72, blocking urine flow therethrough, in addition to thebladder neck 76, thus blocking urine flow from the bladder. This sealingby the body member 21 at the urethera 72 and bladder neck 76 serves toretain urine in the urinary tract until the body member 21 is removedmanually (as detailed below), or by voidance (detailed above).

When voidance is desired, as shown in FIG. 10, the user 80 pulls on thestopper member 36 and the tubular member 22 (shaft 30 and tip region 32)is elongated. This elongation puts pressure on the overcoat layer 24surrounding the bulbous portion 44, and forces fluid from the bulbousportion 44 into the sleeve portion 46, reducing the diameter of thebulbous portion 44. FIG. 11 shows the continued outward pulling of thestopper member 36 by the user 80, such that part of the sleeve portion46 emerges from the meatus 70. The pressure from the urethral walls 74and bladder neck 76 forces fluid 27 to flow into the sleeve portion 46,that expands to accommodate this excess fluid 27. The outward pullingmay also cause part of the bulbous portion 44 to extend beyond thedistal tip 33, as the result of the pressure from the urethral walls 74,that force fluid 27 into the sleeve portion 46. The pulling continuesuntil the body member 21 has been completely removed from the urinarytract.

While the removal procedure detailed above and illustrated in FIGS. 10and 11 is preferred, removal of the body member 21 from the urinarytract by voidance (as discussed above) is also permissible.

Method of Making Polymeric Shapes

To illustrate the application of the present method to forming a shaped,polymeric structure, the embodiment of making a urethral urine retentiondevice (the apparatus 20) of the present invention is described asfollows. The body member 21 of the apparatus 20 of the present inventionmay have components of various lengths and diameters, for example, dueto the varied sizes of the human urinary tract. The manufacturing methoddescribed below is general so as to be applicable for producing varioussized devices in accordance with the present invention.

Referring now to FIG. 12, there is shown a mandrel 100 on which thetubular member 22 and overcoat layer 24, forming the body member 21, isformed. The mandrel 100 (shown attached to a pallet 112 by a connector101) is shaped to include portions corresponding to the shaft 30′, tipregion 32′ (with closed tip 33′) and stopper member 36′. Multiplemandrels, identical to the mandrel 100, shown in the drawing figures,are used simultaneously in the manufacturing process. The mandrels 100are preferably made of a metal or alloy such as stainless steel oraluminum. The mandrels 100 are preferably coated with a polymer havinglow surface energy, such as tetrafluroethylene (e.g., TEFLON) so thatthe completed body members 21 (polymeric structures) can be readilyremoved from the mandrels 100.

Referring also to FIG. 13, there is shown a schematic representation ofa preferred production line 110 which is virtually fully automated. Theautomated production line 110 includes one or more pallets 112 that movethrough various stations 201-231, at predetermined, preferablyequivalent time intervals, where the various processing steps areperformed. The intervals are preferably ten minutes, however, other timeintervals of equal or unequal times are also permissible.

Turning also to FIG. 14, there is shown the processing of multiplemandrels 100 such that multiple body members 21 (polymeric structures)can be produced simultaneously. Each pallet 112 holds a plurality ofelongated mandrels 100, preferably four hundred, typically arranged inrows of twenty by twenty, with the mandrels 100 being spaced apartapproximately one inch (2.54 cm). The moveable pallet 112 is attached toa transport mechanism 120 for moving the pallets 112 between theprocessing stations 201-231 (FIG. 13) for various processing operations.Those processing stations include dip tanks (FIG. 14), drying units,curing ovens, cooling mechanisms, etc.

In FIG. 14, there is shown a dip tank 130, that is used at processingstations 201, 203, 214-217 and 219 (FIG. 13) where dipping occurs. Eachof the respective dip tanks, at processing stations employing dip tanks201, 203, 214-217 and 219 (FIG. 13), are configured similarly to the diptank 130 illustrated in FIG. 14, except the tanks will hold differentsolutions 131 (detailed below) for the requisite processing steps. Themandrels 100 are processed in the dip tank 130 by immersion in therequisite solutions when the respective dip tank is raised and loweredby a lift mechanism 134. This raising and lowering of the dip tank, forpurposes of this disclosure will constitute a “dip” or a “dipping”.Unless otherwise stated, the times provided for the “dip” or “dipping”will include the entire raising and lowering time for the dip tank, andunless otherwise stated, the raising time and the lowering time for thedip tank will be approximately equal.

The processing steps attained by dipping the mandrels 100 in thesolutions in these dip tanks, along with drying, curing and cooling atvarious intervals throughout the manufacturing process creates apolymeric tubular member, shaped residual coating of a bond-preventingagent, and a polymeric overcoat layer, formed on the polymeric tubularmember that is formed on the mandrel 100, at different stages of theprocess, resulting in a shaped structure (body member 21) of the presentinvention.

Movement of the pallet(s) 112 is/are preferably controlled by an outputfrom a computer control mechanism 133, illustrated schematically in FIG.15, which are directed to the transport mechanism 120. The computercontrol mechanism 133 provides outputs for the multiple (1-n) liftmechanisms 134, speed controls 135, depth sensors 137 and timers 139,associated with each dip tank.

Stations with dip tanks (indicated above and below) are such that eachof the respective dip tanks are raised and lowered by associated liftmechanisms 134. The lift mechanisms 134 are also preferably controlledby outputs from the computer control mechanism 133. Each of the liftmechanisms includes a speed control 135 capable of modulating the rateat which the respective dip tank is raised and lowered so that the speedat which the respective mandrels are immersed into and withdrawn fromthe respective fluid within the respective dip tank can be varied,either continuously or intermittently, and either during one dipping orbetween different dippings. The computer control mechanism 133 alsoreceives inputs from depth sensors 137 within each of the respective diptanks. The depth sensors 137, preferably ultrasonic depth sensors 137,are capable of providing an input to the computer control mechanism 133,which enables the computer control mechanism 133 to determine when themandrels 100 are immersed to a desired depth in each respective diptank.

Timers 139 are also provided for each of the respective dip tanks inorder to provide inputs to the computer control mechanism 133 so thatthe computer control mechanism 133 can determine when a desired periodof time has elapsed. A computer program is provided, that moves thepallet(s) 112 along the mechanized production line 110 and raises andlowers the respective dip tanks at predetermined times, at predeterminedrates of speeds, and to predetermined locations and/or heights to enablethe mechanized production line 110 to produce a plurality of completedpolymeric structures (body members 21) (FIGS. 1-4) by dipping themandrels 100 in various dip tanks having various solutions. In alternateembodiments, the mechanized production line 110 may have a series ofpallets (not shown) which are moved along an alternate transportmechanism (not shown) in series.

If desired, the polymeric tubular member 22 can also be provided byeither forming it from suitable tubing (e.g., medically adaptablesilicone rubber tubing) purchased from a commercially available supplier(e.g., Dow Corning), or made by an extrusion process known to thoseskilled in the art. The tubing is then cut to length, with the tipregion 32 attached thereto by adhesives or other equivalent polymerjoining methods, and the stopper member 34 secured thereon by polymerworking methods known in the art. The tubular member 22 is then securedto support rods (not shown) in place of mandrels 100, which can beattached to the pallet 112. Processing of this pre-formed tubular memberwould begin at step (I), in station 214 (FIG. 13) detailed below.

Referring to FIGS. 12 and 16-22, in a preferred embodiment of thepresent method wherein the manufacturing process is automated for massproduction of body members 21 (polymeric structures) of the invention.Approximately four hundred TEFLON-coated stainless steel mandrels 100(FIG. 14) are mounted vertically on a moveable pallet 112. The pallet112 is then moved via a transport mechanism 120 through a series ofprocessing stations 201-231 (FIG. 13). It is preferred that each pallet112 remain within each processing station 201-231 for approximately a 10minute interval, with approximately 30 seconds between each 10 minuteinterval for moving between stations. In cases where individualprocessing stations are a single unit (e.g., stations 209-211 are asingle cure oven, and stations 226-231 are a single petrolatum orpetroleum jelly filled tank), the approximately thirty seconds ofmovement time is built into the total time in the processing station(s).This timing and movement between processing stations is accomplished asthe production process is under computer control and subject to aspecific computer program or programs. The ambient temperature on theproduction line (also referred to as the ambient environment) isapproximately 15.5° C. (60° F.). One manufacturing embodiment is asfollows:

(A) The pallet 112 with a bare mandrel 100 (FIG. 12) is transported tostation 201 over a first tank 130 (FIG. 14), that contains a polymericbonding composition, e.g., an uncured silicone dispersion—a dispersionof General Electric 6030 Silicone (GE 6030) or Dow Corning Q7-4850Silicone (Dow Corning Q7-4850) in heptane, a solvent. The dip tank 130is then raised to immerse the mandrels 100 in the uncured siliconedispersion to a depth to cover substantially the whole length of themandrels 100, such that the uncured silicone rubber dispersion coversthe mandrels 100 up to the level of dash line M (FIG. 16). The dip tank130 is then lowered, this raising and lowering constituting a single“dip”, such a “dip” in this instance being approximately one minute. Thenow coated mandrels 100 are dried for approximately one minute andthirty seconds, allowing for evaporation of the solvent. The drying isby air, at approximately 21° C. (70° F.) being blown through theprocessing station 201. The one minute “dip”, followed by the one minuteand thirty second “dry” is repeated preferably three times. This “dip”and “dry” series, results in an intermediate polymeric structure 250having a first polymeric coating 251 on the mandrel 100 of a thicknessthat corresponds to an inner tube thickness of about 0.76 mm (0.030 in),plus or minus 0.25 mm (0.010 in).

(B) The pallet 112 is then transported to station 202, into a dryingstation, where the coated mandrels 100 are dried for approximately tenminutes (the interval period), allowing for evaporation of the solvent.The drying is by air, at approximately 21° C. (70° F.) being blownthrough the processing station 202.

(C) The pallet 112 is moved to station 203 over a second dip tank(similar to the dip tank at station 201 and as shown in FIG. 14), thatcontains a polymeric bonding composition, e.g., an uncured siliconedispersion—a dispersion of General Electric 6030 Silicone (GE 6030) orDow Corning Q7-4850 Silicone (Dow Corning Q7-4850) in heptane, asolvent. In an approximately one minute “dip”, the dip tank is thenraised to immerse the mandrels 100 in the uncured silicone dispersion toa level corresponding to dashed line T (FIG. 17). The dip tank is thenlowered, completing the “dip”, and the now coated mandrels 100 are driedfor approximately one minute and thirty seconds, allowing forevaporation of the solvent. The drying is by air, at approximately 21°C. (70° F.) being blown through the processing station 203. The oneminute “dip”, followed by the one minute and thirty second dry isrepeated preferably three times. These “dip” and drying steps, result ina second polymeric coating 252 of a thickness at the intermediate tipregion 32″ (including the intermediate tip 33″) preferably about 0.76 mm(0.030 in) (FIG. 17).

(D) The pallet 112 is then transported to stations 204-207 where thecoated mandrels are dried for approximately 40 minutes, allowing forevaporation of the solvent. The drying is by air, at approximately 21°C. (70° F.) being blown through the processing stations 204-207.

(E) The pallet 112 is then moved to an empty station 208, where thecoated mandrels 100 dry in the ambient environment.

(F) The pallet 112 then moves to a cure oven, formed by the combinationof stations 209-211. This cure oven is at 110° C. (230° F.), and thecoated mandrels remain therein for approximately thirty minutes, suchthat the silicone on the mandrels 100 can properly cure.

(G) Next, the pallet 112 is moved to station 212, where it is dippedinto a tank of water at 15.5° C. (60° F.), for preferably a singleapproximately four minute “dip”. This “dip” is performed to cool themandrels 100.

(H) The pallet 112 is then moved to an empty station 213, where thecoated mandrels 100 dry in the ambient environment.

(I) The pallet 112 is then moved over a dip tank (similar to the diptank 130 at station 201, as shown in FIG. 14), at station 214. Stations214-218 are isolated from the other stations on the production line 110,to accommodate air being blown therethrough at approximately 15.5° C.(60° F.). The dip tank at station 214 contains a bond-preventing agent,such as petroleum jelly or petrolatum, preferably a liquid petrolatummixture at about 52° C. (about 125° F.). The mixture will includePerfecta™ Petrolatum USP (from Sonneborn Petrolatums, Sonneborn Div.,Witco Chemical Corp., New York, N.Y.). The tank is raised so as toimmerse the coated mandrels 100 to a depth up to dashed line A, as shownin FIG. 18. The dip tank is then lowered, such that coated mandrel 100is further coated with a first coating 255 of petrolatum. This “dip” inthe dip tank is approximately thirty seconds long, and once the “dip” iscomplete, the coated mandrels 100 are dried and cooled for anywherebetween 60 and 150 seconds. The drying is by air, at approximately 15.5°C. (60° F.) being blown through the processing station 214. The “dip”and subsequent drying steps are repeated, preferably three times untilthe first coating 255 is built up to a desired thickness. Preferably,this thickness is about 0.76 mm to 1.78 mm (0.030 in to 0.070 in). The“dips” in this processing step are such that some rundown or sag in theliquid petrolatum or petroleum jelly occurs prior to its solidifying, asit cools on the surface of the coated mandrel 100, causing the firstcoating 255 to be somewhat tapered. The amount of the taper iscontrollable by controlling the withdraw speed of the dip tank and theambient temperature.

(J) The pallet 112 is then moved over a dip tank (similar to the diptank 130 at station 201, as shown in FIG. 14), at station 215 whichcontains a bond-preventing agent, such as petroleum jelly or petrolatum,preferably a liquid petrolatum mixture at about 52° C. (125° F.). Themixture will include Perfecta™ Petrolatum USP (from SonnebornPetrolatums, Sonneborn Div., Witco Chemical Corp., New York, N.Y.). Thetank is raised so as to immerse the coated mandrels 100 to a depth up todashed line B, as shown in FIG. 19. The dip tank is then lowered, suchthat coated mandrel 100 is further coated with a second coating 257 ofpetrolatum. This “dip” in the dip tank is approximately thirty secondslong, and once the “dip” is complete, the coated mandrels 100 are driedand cooled for anywhere between 60 and 150 seconds. The drying is byair, at approximately 15.5° C. (60° F.) being blown through theprocessing station 215. The “dip” and subsequent drying steps arerepeated, preferably three times until the second coating 257 is builtup to an additional thickness. Preferably, this additional thickness isabout 0.76 mm to 1.78 mm (0.030 in to 0.070 in).

(K) The pallet 112 is then automatically advanced to station 216 andstopped over a dip tank (similar to the dip tank 130 at station 201, asshown in FIG. 14), that contains hot USP petrolatum or petroleum jellyheated to about 88° C. (190° F.). This hot USP petrolatum (or petroleumjelly) serves as both a shaping and a stripping agent. Controlleddipping in this hot USP petrolatum allows for the first 255 and second257 petrolatum coatings to be largely removed in a desired manner (bymaterial addition and stripping). The dip tank is raised so as toimmerse the coated mandrel 100 in the super-heated petrolatum forapproximately five seconds to dashed line S. The dip tank is immediatelylowered (pulled-back) to dashed line C, such that portions of thepetrolatum are left on top of the first coating 255, forming firstshoulders 258 at the top edges of the first coating 255 (indicated bydashed line A), and portions of the petrolatum left on the secondcoating 257, form second shoulders 259 at the top edges of the secondcoating 257 (indicated by dashed line B). This pull-back to dashed lineC takes a total of about five seconds, and serves to provide shape tothe intermediate sleeve portion 46″ and part of the intermediate bulbouspotion 44″, as shown in FIG. 20. This lowering (pull-back) continues,for approximately twenty seconds, as the dip tank is moved from dashedline C to dashed line T, so that the lowering of the dip tank allows formelting of the first 255 and second 257 petrolatum coatings, such thatthe first 255 and second 257 coatings gradually curve inward, providingshape to a portion of the intermediate bulbous portion 44″, as shown inFIG. 20. Once at dashed line T, lowering (pull-back) pauses (in a dwell)for approximately two minutes as the first 255 and second 257 petrolatumcoatings are melted off of (stripped from) the intermediate tip region32″, such that only the silicone elastomer coat (second polymeric coat252) remains (FIG. 21).

(L) The pallet 112 is then automatically advanced to station 217 andstopped over a dip tank (similar to the dip tank 130 at station 201, asshown in FIG. 14), containing a volatile organic solvent such astoluene, trichloroethane or the like. The tank is then raised to immersethe coated mandrel 100 to the depth indicated by dashed line T, therebyremoving essentially all traces of the petrolatum from this portion ofthe second polymeric coating 252. This step is preferably performed witha single, approximately four minute “dip” to enhance thesilicone/silicone bond between the first 251 and second 252 polymericcoatings at the intermediate tip region 32″, and to free theintermediate tip region 32″ of petrolatum.

(M) The pallet 112 is then transported to station 218 where theintermediate structures 250 are dried for approximately ten minutes. Thedrying is by air, at approximately 15.5° C. (60° F.) being blown throughthe processing station 218.

(N) The pallet 112 is then automatically advanced to station 219 havinga dip tank (similar to the dip tank 130 at station 201, as shown in FIG.14), containing a hexamethyl disiloxane silicone rubber dispersion whichis effective to minimize any disruption of the integrity of thepetrolatum (or petroleum jelly) coatings remaining on the intermediatestructure 250. Although the present apparatus 20 can be constructed ofany suitable, medically acceptable, polymeric material, medical gradesilicone rubber is preferred. The silicone rubber of the sleeve overcoatpreferably is soft, with a hardness of about 20 to 40 durometer, morepreferably about 30 durometer. It will be appreciated that such asilicone rubber polymeric coating layer must be fully cured prior tosale or use of the apparatus 20. The overcoat layer 24 can have athickness of about 0.05 mm to 0.77 mm (0.002 in to 0.030 in), preferablyabout 0.13 mm (0.005 in) plus or minus 0.05 mm (0.002 in). The preferreduncured silicone rubber dispersion is a very soft uncured siliconerubber dissolved in weak solvent that will not disrupt the petrolatum orpetroleum jelly. An effective uncured silicone rubber dispersion formaking the present invention is a 25-75 mixture of uncured siliconerubber in hexamethyl disiloxane. This mixture is made of GE 6030 orDow-Corning Q7-4850 in hexamethyl disiloxane. The dip tank is thenraised to immerse essentially the entire length of the intermediatestructure 250 in the silicone mixture to dashed line M, and thenlowered, to complete the “dip”. The “dip” lasts for approximately 45seconds, resulting in the intermediate structure 250, shown in FIG. 22,having a third polymeric coating 261. This dip is followed by anair-dry, lasting approximately two to two and one half minutes, as airat approximately 21° C. (70° F.) is blown through the processing station219. The “dip” and subsequent air-drying steps are repeated, preferablytwo times, such that this third polymeric coating 261 (that ultimatelyserves as the overcoat layer 24), as a result of these “dips” and“dries” becomes rounder at the intermediate bulbous portion 44″.

(O) The pallet 112 is then moved to an empty station 220, where thecoated mandrels 100 dry in the ambient environment.

(P) The pallet 112 is then transported to stations 221-225 where theintermediate structures 250 are dried for approximately 50 minutes. Thedrying is by air, at approximately 21° C. (70° F.) being blown throughthe processing stations 221-225.

(Q) The pallet 112 is then lowered into a tank at a constant height, thetank occupying stations 226-231, and filled with hot USP petrolatum atapproximately 116° C. (240° F.). The intermediate structures 250 (FIG.22) on the mandrels 100 are immersed up to dashed line M and advanced atthat level for approximately one hour, before removal from thisstationary tank. This processing step serves to cure the third polymericcoating 261, placed onto the intermediate structure 250 at step (N)above, without disrupting the shape of the structure as would occur witha hot air oven (as is done conventionally).

(R) The now formed intermediate structures 250 (body members 21) arethen preferably taken off of the production line (stations 201-213) andin a separate production step, are soaked for preferably about 24 to 36hours, in a hot bath of mineral oil at about 116° C. (240° F.). Themineral oil will generally replace the petrolatum coatings 255, 257(FIGS. 19 and 20), encased within the third polymeric coating 261 (FIG.22), by osmosis, after this period of time, and the mineral oil willremain a liquid at room temperature. The mineral oil has a significantlylower viscosity than petrolatum at room temperature. A different fluidsuch as water, sterile saline, glycerin, polyethylene glycol, gas (e.g.,air) and the like, or appropriate mixtures thereof may also besubstituted for the mineral oil/petrolatum fluid in alternateembodiments by removing most of the latter liquid, and then insertingthe former by appropriate means.

(S) The now completed body members 21 are then loaded with a stylet 28(FIG. 1), sterilized by conventional sterilization techniques, e.g.steam, ethylene oxide vapor, irradiation, or the like, and packaged bypackaging techniques known in the medical device art. If desired, thispackage can be sold as a kit commercially.

The above described method for producing the body members 21 (polymericstructures) of the present invention allows for the manufacture of thesedevices at the rate of about 2,400 pieces per hour. Because minimal, ifany, hand work is involved, the body members 21 will be produced withconsistency, high quality and economically.

While the invention has been described in connection with an embodiment,it will be understood that the invention is not limited to thatembodiment. The invention is intended to cover all alternatives,modifications and equivalents as may be included within the spirit andscope thereof, as determined by the claims.

What is claimed is:
 1. A device for use within a patient's urinary tractfor blocking the flow of urine therein, comprising: (a) a deformablebody member adapted for partial insertion into the male urethra, saidbody member having a shape retaining memory and including a deformablefluid filled cavity, said fluid filled cavity extending along said bodymember, and having a proximal end and a distal end; (b) at least aportion of said body member having an at rest diameter greater than thatof an undilated male urethra of the patient's urinary tract, said bodymember including a distally positioned bulbous portion and a proximallypositioned sleeve portion, the diameter of the bulbous portion at itswidest point being greater than the diameter of the sleeve portion. 2.The device of claim 1, wherein said deformable member is adapted forinsertion into approximately the first 13-18 cm of the male urethra. 3.The device of claim 2, wherein said deformable member is adapted forinsertion into approximately the first 15-17 cm of the male urethra. 4.The device of claim 3, wherein said deformable member is adapted forinsertion into approximately the first 15 cm of the male urethra.
 5. Thedevice of claim 3, wherein said deformable member is adapted froinsertion into approximately the first 15.2 cm of the male urethra. 6.The device of claim 1, wherein said portion of said body member has anat rest diameter greater than 5 mm.
 7. The device of claim 6, whereinsaid portion of said body member has an at rest diameter greater than5.5 mm.
 8. The device of claim 7, wherein said portion of said bodymember has an at rest diameter greater than 6.3 mm.
 9. The device ofclaim 1, wherein said fluid filled cavity is constructed and arranged todeform upon insertion of said body member into the urethra, and uponsaid continued insertion of said body member through said urethra intoat least the spongy portion of the urethra, at least a portion of saidfluid filled cavity at said distal end expands toward a diameter atleast as great as said rest diameter, as the pressure from the walls ofsaid urethra compress on at least a portion of said fluid filled cavityat said proximal end, causing fluid flow toward the distal end of thefluid filled cavity.
 10. A device for use within a patient's urinarytract for blocking the flow of urine therein, comprising: (a) adeformable body member adapted for partial insertion into the urethra,said body member having a shape retaining memory and including adeformable fluid filled cavity, said fluid filled cavity extending alongsaid body member, and having a proximal end and a distal end; (b) adeformable shaft member that is positioned within said deformable bodymember, and has a proximal and distal end.
 11. The device of claim 10,wherein said proximal and distal ends of said deformable shaft memberhave pre-insertion diameters that are less than an undilated urethra.12. The device of claim 10, wherein said distal end of said deformableshaft member has a post-insertion diameter that is greater than thebladder neck.
 13. The device of claim 10, wherein said proximal anddistal ends of said deformable shaft member have pre-insertion diametersthat are less than an undilated urethra and said distal end of saiddeformable shaft member is wider upon insertion of said device into theurethra.
 14. The device of claim 10, wherein said fluid filled cavity isconstructed and arranged to deform upon insertion of said body memberinto the urethra, and upon said continued insertion of said body memberthrough said urethra past the bladder neck, said distal end of saiddeformable shaft member increases in diameter.
 15. The device of claim10, wherein said proximal and distal ends of said deformable fluidfilled cavity have approximately equal diameters.
 16. The device ofclaim 10, wherein said deformable fluid filled cavity has at least tworegions where the diameter changes.
 17. A device for use within apatient's urinary tract for blocking the flow of urine therein,comprising: (a) a deformable body member adapted for partial insertioninto the urethra, said body member having a shape retaining memory andincluding a deformable fluid filled cavity, said fluid filled cavityextending along said body member, and having a proximal end and a distalend, wherein said proximal and distal ends have approximately equaldiameters; (b) a deformable shaft member that is positioned within saiddeformable body member, and has a proximal and distal end, and has adiameter less than an undilated urethra before insertion, and afterinsertion into a urethra is deformed with a resulting diameter greaterthan the bladder neck.